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FRIDAY, JUNE 23, 2006

Session 7: Public Comments

Troy Zimmerman
Paul Billings
Thomas McCome
Debra Budiani

CHAIRMAN PELLEGRINO:  Other questions, comments?  If there are none, with your permission, we'll move to the last item on the agenda which is the time we allow for public comments.  I have one, two, three, four requests.  I want to inform those who will be speaking that we have a rule that limits those presentations to five minutes.  And simply to advise a little in a friendly way that the most effective messages are the ones which are brief, crisp, to the point, premeditated and I think you'll find that that's the best way to make an impress rhetorically in a short time. 

I'll first call on Troy Zimmerman from the National Kidney Foundation and Dr. Davis will keep close — you may go to the microphone, please.  I was just going to say, Dr. Davis will be advising me on the time elapse.  Unfortunately, I am the chronoscopist by designation.

MR. ZIMMERMAN:  Good morning, I'm Troy Zimmerman.  I'm the Director of Government Relations for the National Kidney Foundation and I would like to comment today on your deliberations from yesterday's discussions.  The National Kidney Foundation is active in all aspects of organ donation and transplantation of all solid organs.  We are committed to increasing the number of organ donors, however, economic incentives constitute payment for organs and are inconsistent with our values as a society. 

We endorse the recommendations and findings in the Institute of Medicine's May 2006 Organ Donation Report that financial incentives, whether direct payment, funeral expenses or expression of gratitude should not be used to increase organ donation.  As the IOM panel stated, even on a trial basis, this would be easy to start but very difficult to stop. 

The sale of body parts would undermine the fundamental values of our society, diminish human dignity and exploit the most vulnerable members of our society.  Financial incentives could impact altruistic donation, closure for donor families and society at large.  As the Council heard yesterday morning, many Americans are not inclined to be organ donors because of their distrust of the organ donation process or of the health care system in general.  Financial incentives would intensify this distrust.

Proponents of financial incentives for non-living organ donation assert that demonstration projects should be conducted to determine whether it will increase the organ supply.  As the IOM panel stated, it is not feasible to design a pilot project on financial incentives.  The National Kidney Foundation suggests that emphasis should be in other areas, including the following; building on success of the organ donation break-through collaborative and best practices, providing additional support through the congressional appropriations process to fund the organ donation recovery and improvement act of 2004, Public Law 108-216, providing reimbursement for travel and subsistence expenses for living donors as authorize in Public Law 108-216, enactment of S-2306 introduced in this Congress by Senator Levin to clarify that kidney paired and kidney list donations do not constitute valuable consideration in the transfer of a human organ.  Some transplant experts estimate that a national registry, a national data base of medically incompatible couples could result in as many as 2,000 additional transplants annually. 

Encouraging employers to provide paid leave to living organ donors, an expansion of state legislation to reduce barriers to living organ donations such as paid leave for state employees, which many states have done already, business tax deductions to offset the expense of paid leave and state income tax deductions to assist living donors with unpaid expenses.  Thank you for the opportunity to present our views.

CHAIRMAN PELLEGRINO:  Thank you very much.  Dr. Rowley.

DR. ROWLEY:  Can I ask you a question?  How certain are you that financial inducement will increase distrust amongst particularly minority populations?

MR. ZIMMERMAN:  I think it would particularly be a problem in the minority populations given that —

DR. ROWLEY:  You think, but I'm asking for data.

MR. ZIMMERMAN:  I don't have data.

DR. ROWLEY:  Okay.  So that's one point that I want to make.  And the other is in a pluralistic society, should there be multiple ways of solving a problem?

MR. ZIMMERMAN:  I believe so.

DR. ROWLEY:  But then you're asking for the continued prohibition of financial reimbursement for a organ.

MR. ZIMMERMAN:  I believe we've laid out some alternatives, and we think there's certainly more than one way to address a shortage but we stand opposed to financial incentives even on a trial basis.  I think it could be counter-productive in terms of the impact on altruistic donations.  Many of the things that were stated in the Institute of Medicine report we support those findings.

DR. ROWLEY:  Well, I'm a member of the Institute of Medicine and I'm — you know, I certainly support some parts of that but I come back to my notion, in a pluralistic society, I'm not sure the prohibitions are appropriate.  I should say all prohibitions are appropriate.

CHAIRMAN PELLEGRINO:  Thank you very much.  Further — no? 

MR. ZIMMERMAN:  Thank you.

CHAIRMAN PELLEGRINO:  Next, I would like to call on Dr. Paul Billings of Lab Corp.

DR. BILLINGS: Thank you very much for letting me listen to this very interesting discussion this morning and for making a comment.  I'm a Fellow of the American College of Physicians, founding Fellow of the American College of Medical Genetics, a Professor at Cal but I'm here as — in my day job as the Senior Vice President and Senior Geneticist of Laboratory Corporation of America.  Of the more than 300 million tests that we provide the American health care system every year, a significant number of those are genetic tests and they've improved the lives of many Americans over the years.

In general, the state Public Health Agencies have done an excellent job of assuring equitable and universal access to reliable screening for restricted and somewhat regional variable set of disorders.  It is essential that these programs be of high quality and fairly distributed since they are provided generally without informed affirmative consent by the parents.  Most families have no idea that testing has occurred and often know little about the disorders or the risk of having them before the screening results are available.

The provision of screening, as we've heard already this morning, has provided some key lessons.  I'm just going to touch upon a couple and then add one.  The screening tests and their normal and abnormal reference ranges require stringent validation prior to the inclusion and broadly applied panels.  The experience of labeling benign fetal al — anemia  as PKU and then subjecting these normal children to treatment that harm them should never be forgotten.  While the provision of early detection for any disorder may offer significant benefits, it also brings responsibilities to the health care system.  Abnormal screening results require confirmation and then often life-long services to insure a salubrious result.  Vigilance to the remaining risk associated with false negative result also must be emphasized.  In some cases there are very few individuals in a country who know how to properly treat individuals with rare or orphan disorders.

Many state based public health care systems are not designed nor funded to deliver follow-up or long-term care and private sector resources may also be not available.  System failures in the absence of needed programs undermine the benefits of broad-based screening.  This is not a particularly profound point.  Rapid advances in knowledge and laboratory methods have created new tests to confirm current screening results accurately and in a cost-effective manner and have also offered very significant opposition to expansive screening and a much larger universal risk.

Some conditions proposed for new screening efforts represent rare and morbid disorders in pediatric patients much like the current panels, but others may be chronic disorders of childhood or adulthood that can be prevented or delayed or where recognition of risk can allow for adverse events to be avoided; take for instance, Type 1 diabetes and the presentation of Type 1 diabetes.  Some have suggested that purely developmental disorders of childhood, for instance, Fragile X syndrome and autism, should also be identified at birth so that planning and supplemental care can be promptly undertaken. 

The establishment of a public health consensus approach to the expansion of newborn testing will be difficult.  Expectations about medicine and choice are changing.  The provision of new screening tests in the absence of very significant involvement by the private sector will be impossible.  In response to market demands the private sector will work to deliver cost effective tests for all current and contemplated newborn conditions.  Luminex and Affymetrix, by the way, are private sector enterprises.  These may be quality controlled and distributed in collaboration with state public health establishments, but I strongly believe that consumer and technology demands will require the involvement of commercial laboratory and biotechnology sectors to best serve society's needs.

Increasing capability to accurately identify and successfully treat disease or prevent illness when significant risks exist requires both public and professional education reform and aggressive supplementation.  If these programs are created and provided, they may significantly alter how we care for a variety of conditions beginning at conception.

So in conclusion, the demonstrated success of newborn screening programs and the rapid evolution of knowledge and testing capability suggests the need to rethink how we will equitably make available proven technologies.  We must consider a variation of family need, individual choice and traditional manners for consent before applying medical technologies.  Stimulating market innovation and enterprise while fostering new types of public/private collaborations for universal provision and long-term follow-up will likely be needed.  As a major national provider of high quality innovative clinical laboratory services, LabCorp stands ready to work with other parties in the health care system to provide all newborns with appropriate screening and testing.  Thank you.

CHAIRMAN PELLEGRINO:  Thank you very much.  Dr. Rowley?

DR. ROWLEY:  In part my question, it's a follow-on of something I just had to ask Dr. Alexander in private and that relates to are you currently using DNA testing amongst the modalities that you use in your laboratory, and secondly, if you're not, how soon do you think you're going to incorporate or do you anticipate incorporating DNA analysis into your test modalities?  And if you've already used it, do you have any preliminary data on whether Dr. Alexander's notions of false positives are going to be diminished?

DR. BILLINGS: Well, so are you asking about the universe of genetic disorders, are you asking about newborn screening, Dr. Rowley?  What exactly are you asking about?

DR. ROWLEY:  Well, since the focus of this morning's session has been newborn screening, I suppose that that has to be an important component but I'm curious because Dr. Bloom has suggested that we expand from DNA analysis of newborns to other genetic disorders, a broader response would be appropriate if the Chairman thinks we have time.

DR. BILLINGS: Sure.  So as you well know, for pediatric disorders of which the concern has been this morning, chromosomal analysis and proteomic biochemical based testing has been the norm, the tradition.  For some follow-up, obviously, of certain screened results, DNA testing is now part of the confirmatory panel that we apply.  We are generally not a provider of newborn screening but we are a provider of the confirmatory testing that's involved in follow-up, false negative, false positive and so forth work, that's done in some states.

The answer to your question about the accuracy, fundamentally, we've found, of course, primarily driven by infectious disease molecular testing, but also by some rare genetics that, in fact, the cost and accuracy of DNA based testing is improved over sometimes rare, variable but proteomic or biochemical testing, but this, of course, requires that we have the data base to know what — how to interpret genetic variance and as you also know, when one looks carefully at any particular gene, one finds variance often that didn't — aren't expected, we don't understand the phenotypic implications.

So that's a lot of the long-winded answer saying I think what Dr. Alexander was saying is, in fact, true.  I think the cost will come down with molecular platforms with DNA platforms, but they require databases and phenotype, genotype correlation, information databases to be broadly available to the laboratories who are providing it.

CHAIRMAN PELLEGRINO:  Thank you very much.  Next, I would like to call on Thomas — Dr. Thomas McCome of the American Foundation for Donation and Transplantation.

DR. McCOME:  Thank you for the opportunity. My name is Thomas McCome.  I'm a Transplant Nephrologist from Norfolk, Virginia.  I'm here for the American Foundation for Donation and Transplantation.  I'm here to discuss the Living Organ Donor Network, which is a program that is a registry of living organ donors, primarily kidney donors.  We began in October of 2000.  This is a voluntary participation by the organ donor. 

Since October 2000 we have a registry that is currently covering about 1,000 kidney donors, 1,063.  Considering that every year we do about 6,000 living kidney donations a year, that's a drop in the bucket.  We have 19 centers who are participating voluntarily in this registry.  That's 19 out of 257, again, a very small number.  Donors like this, they fill out their questionnaires, they send their information back.  This information then goes back to the transplant programs to help them improve their technique, their care of the donor.

Additionally, that information, complications, time back to work, is all being tracked.  We're going to use that.  We've published it once.  We're going to continue to publish that data so that donor programs can say, "Well, donors report they would go back to work at this time.  Donors report they're driving at this point".   Additionally, it's a way for us to track complications.  Donors report complications differently than the transplant programs report complications.  Frequently, complications occur after the donor has left their transplant center and gone back home. 

The most intriguing part of this registry is an insurance policy.  There's an insurance policy that costs a one-time charge to the transplant center of $550.00.  This covers the life of the donor from the time they're admitted to the hospital for their donation surgery up to a year.  It covers accidental death due to complications from the transplant donation.  It covers disability insurance for up to five years and — from complications and it provides for medical coverage for costs that are not necessarily covered by the recipient's insurance.

Frequently the recipient's insurance will not cover outpatient charges and that continues to be a real problem.  So far since we've initiated this program, we've covered 257 lives, only 257 lives over this five-year period, six-year period, excuse me.  That's four centers are enrolling all of their patients and two individuals have actually purchased this insurance independently on their own.

Donation is dangerous.  Donors have died.  Donors will continue to die.  If you compare organ donation to say laparoscopic cholecystectomy, there's a risk of that.  One in about 6,000, one in about 10,000 of those individuals will die in surgery.  We do 6,000 kidney transplants a year.  We're overdue.  When I talk to programs, they're not willing to accept that this is an intrinsically dangerous procedure.  They say, "Well, we don't have complications".  Well, I'd much rather be lucky than good, but you can't always be lucky.  Our program has begun this as well.

What I ask from you is that you recognize the risk that donors willingly accept to donate and encourage all transplant programs to work to protect the lives and the well-being of the donor and their family from this donation procedure.  I encourage kidney donation.  We're one of the biggest programs in the state right now and this is something that we agree with.

CHAIRMAN PELLEGRINO:  Thank you very much.  If there are no comments, next we have a request for a statement by Jana Monaco of the Organic Acidemia Association.  I understand I'm to read this.

"Good morning.  I am a parent of two children with an inborn error of metabolism called isovaleric acidemia that is detectible at birth.  My son Steven, now eight and a half years old, was diagnosed five years ago after going into a metabolic crisis.  His late diagnosis resulted in severe brain damage.  He is now a severely disabled child with complex medical issues including G-tube feeding and uncontrollable seizures".  I'm reading this as is.

"He does not walk or talk nor can he sit up on his own and his medical care costs continue to soar.  He is far from the happy-go-lucky and healthy little boy that he once was.  Our daughter, Caroline, is three and a half and was fortunate to be diagnosed with prenatal testing enabling immediate treatment and management of her disorder.  Today, she is a bright and healthy child with a promising future.  She is always the reminder of what Steven was and could be had — could had he been screened at birth.  His family suffers every day from the consequences of inadequate newborn screening at the time of Steven's birth. 

I have dedicated my time to his care and that of my other three children and advocacy for expanded newborn screening.  We have been successful at the state level by getting legislation passed to expand Virginia's detectible disorders and I have also been immensely involved on the federal level.  I am on the Laboratory and Procedures Subcommittee of the Advisory Committee for Heritable Disorders and Genetic Diseases in Newborns and Children. 

Having witnessed the incredible amount of time and work involved in the ACMG recommendation of disorders to be screened to the Secretary of HRSA, I find it quite daunting to continue to listen to individuals question the ethics of newborn screening.  Every possible concern and issue related to the topic is and has been addressed by the committee and is being handled.  Many individuals claim to be knowledgeable on the subject yet I have never seen them present at any of the advisory committee meetings. 

I have been to every one of them.  I attend these meetings because I want to insure that children are protected from experiencing the same tragedy like my Steven.  I ask this Council how ethical is it to allow babies to be denied screening that could detect one of these deadly disorders?  We live in a country whose constitutional rights guarantee us equality.  Our son's equality was denied because he did not receive the same comprehensive screening that our neighboring state of North Carolina provided like others at the time of this birth. 

Is that ethical?  Is it unfortunate that some people have the opportunity to interpret ethics to suit their own beliefs, yet have the potential to have a tremendous impact on the lives of others?  I question the moral standards of these individuals that would prefer to interfere in a process implemented to save lives.  As I witness my son's daily seizures, though he takes three different medications and feed him his formula through his gastrostomy tube, change his positions and conduct his therapy sessions, I remind myself that this is a result of someone's so-called ethics and I am determined to insure that those ethics do not continue to influence people's lives.

Thank you, Jana Monaco, Board of Directors, Organic Acidemia Association, 3175 Ironhorse Drive, Woodbridge, Virginia, 22192, phone number 703-497-1216". 

Do I have someone to comment?  Someone in the audience?  We have one more person who has asked to speak.  Dr. Debra Budiani, I hope I have that correct, from the University of Pennsylvania, Center for Bioethics and the Coalition for Organ Failure Solutions.

DR. BUDIANI:  Thank you for this opportunity.  I've worked in an advocacy position with organ sellers and related donors in the developing world since 1999.  I'm conducting follow-up and outreach services.  The data is still preliminary but our findings have been very consistent with other reports of significant adverse outcomes.  I'm concerned then primarily with the exploitation of vulnerable individuals of kidney donorship and other organ donorship and I have a question, comment for Dr. Hippen's proposal.  I'm not sure if he's here still but I'd like to raise the question.

In addition to protecting potential exploitation of vulnerable potential donors from — via market forces, a strength of the current organ procurement and distribution system in the United States is its aim to develop equitable organ distribution policies that maximize the limited supply of organs.  Equitable distribution making organs available to the poor has also been a commitment of the Iranian system via government subsidized organ purchases.  Dr. Hippen's policy proposal appears to further enable those patients who could provide financial incentives to obtain an organ but I'd like to understand if it actually addresses the concerns of those who could not afford to do so.  Thank you.

CHAIRMAN PELLEGRINO:  Thank you very much.  A word of explanation for all of you who do not know the procedure here, if anything is to be gotten into the record by a non-member of the Council, the Chairman is expected to read it, that is why I read that statement, so it will get into the regular meeting account and be a part of the record.  I apologize if I've in any way not put the proper emphasis in the proper places but it was the first time I saw this statement. 

I think we are that point where I can thank the members of the Council for their participation, all who addressed us.  I wish all of you on the Council and all of you in the audience a very happy summer.  We will be, during the summer, we and the staff are looking at the report of this particular meeting and the other meetings and trying to arrive at the questions you raised properly, Dr. Rowley, earlier and which many of the Council members have expanded on and we're grateful for that on how we focus and what we do next.  And I hope I can promise on behalf of the staff that we will have a set of suggestions or directions to go in and particularly how to deal with this last question which, I agree thoroughly with all of you is a very complex one and certainly Dr. Kass, a question of either completing what was started or whether there is a place for a statement, will be looked at as critically as planned and we'll be back to you with a suggestion. 

Thank you very much, and have a good summer.

(Whereupon, at 11:58 a.m. the above-entitled matter concluded.)

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